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OJJAARA Drug Patent Profile

When do Ojjaara patents expire, and when can generic versions of Ojjaara launch?

Ojjaara is a drug marketed by Glaxosmithkline and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-nine patent family members in thirty-five countries.

The generic ingredient in OJJAARA is momelotinib dihydrochloride. One supplier is listed for this compound. Additional details are available on the momelotinib dihydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Ojjaara

Ojjaara will be eligible for patent challenges on September 15, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 15, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OJJAARA

International Patents:	89
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for OJJAARA
What excipients (inactive ingredients) are in OJJAARA?	OJJAARA excipients list
DailyMed Link:	OJJAARA at DailyMed

See drug prices for OJJAARA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OJJAARA

Constraining patent/regulatory exclusivity:

TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF OR SECONDARY MF [POST-POLYCYTHEMIA VERA (PV) AND POST-ESSENTIAL THROMBOCYTHEMIA (ET)], IN ADULTS WITH ANEMIA

NDA:

216873

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for OJJAARA

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for OJJAARA

OJJAARA is protected by three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF OR SECONDARY MF [POST-POLYCYTHEMIA VERA (PV) AND POST-ESSENTIAL THROMBOCYTHEMIA (ET)], IN ADULTS WITH ANEMIA.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OJJAARA

FDA Regulatory Exclusivity protecting OJJAARA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-002	Sep 15, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-003	Sep 15, 2023		RX	Yes	Yes
Glaxosmithkline	OJJAARA	momelotinib dihydrochloride	TABLET;ORAL	216873-001	Sep 15, 2023		RX	Yes	No			Y	Y

International Patents for OJJAARA

See the table below for patents covering OJJAARA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2951883	SELS DE CHLORHYDRATE DE N-(CYANOMETHYL)-4-(2-(4-MORPHOLINOPHENYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE (N-(CYANOMETHYL)-4-(2-(4-MORPHOLINOPHENYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE HYDROCHLORIDE SALTS)
Taiwan	I681954
Cyprus	1123604
Hungary	E051360
Morocco	40067	SELS DE CHLORHYDRATE DE N-(CYANOMÉTHYL)-4-(2-(4-MORPHOLINOPHÉNYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE (N-(CYANOMETHYL)-4-(2-(4-MORPHOLINOPHENYLAMINO)PYRIMIDIN-4-YL)BENZAMIDE HYDROCHLORIDE SALTS)
Hungary	E029188
Croatia	P20151386